Cleared Traditional

K894039 - QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION

K894039 is the FDA 510(k) clearance for QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION by Quidel Corp.. It is a Class 2 Immunology device (product code DGO) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K894039 · Quidel Corp. · Immunology device
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Jul 1989
Decision
38d
Days
Class 2
Risk

K894039 is an FDA 510(k) clearance for the QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quidel Corp. devices

Submission Details

510(k) Number K894039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1989
Decision Date July 14, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGO Ige, Peroxidase, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DGO Ige, Peroxidase, Antigen, Antiserum, Control

All 7
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K894039.
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K872801 · Diagnostic Products Corp. · Sep 1987
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K860851 · Nichols Institute Diagnostics · Mar 1986